Product code MDB
- Device name
- System, Blood Culturing
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2560
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222591 | BD BACTEC™ Plus Aerobic/F Culture Vials | Becton, Dickinson and Company | 2023-03-24 |
| K222559 | BD BACTEC™ Myco/F Lytic Culture Vials | Becton, Dickinson and Company | 2023-03-24 |
| K190405 | BACT/ALERT MP Reagent System | bioMerieux, Inc. | 2019-05-15 |
| K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | bioMerieux, Inc. | 2019-02-11 |
| K173873 | BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial | Becton, Dickinson and Company | 2018-03-16 |
| K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO | bioMerieux, Inc. | 2017-03-28 |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | Becton Dickinson | 2017-02-09 |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | Becton Dickinson | 2016-08-08 |
| K151866 | BD BACTEC Peds Plus/F Culture Vials (plastic) | Becton, Dickinson and Company | 2016-02-25 |
| K141810 | BD BACTEC PLUS ANAEROBIC/F (PLASTIC) | Becton, Dickinson and Company | 2014-12-10 |
| K123903 | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) | Becton, Dickinson & CO | 2013-05-13 |
| K121446 | BACT/ALERT PF PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-25 |
| K121455 | BACT/ALERT FN PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-25 |
| K121461 | BACT/ALERT FA PLUS CULTURE BOTTLE | bioMerieux, Inc. | 2013-01-22 |
| K120994 | BD BACTEC Plus PRIME Aerobic/F Culture Vials | Becton, Dickinson and Company | 2012-08-07 |
| K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic) | Becton, Dickinson and Company | 2012-03-16 |
| K083572 | BD BACTEC Plus Aerobic/F Culture Vials | Becton, Dickinson & CO | 2008-12-24 |
| K032306 | VERSATREK | Trek Diagnostic Systems, Inc. | 2003-08-22 |
| K031737 | BACT/ALERT MP CULTURE BOTTLES (PLASTIC) | bioMerieux, Inc. | 2003-07-14 |
| K021123 | BACT/ALERT SN CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-26 |
| K020923 | BACT/ALERT PF CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-18 |
| K020931 | BACT/ALERT SA CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-18 |
| K020815 | BACT/ALERT FN CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-18 |
| K020813 | BACT/ALERT FA CULTURE BOTTLE | bioMerieux, Inc. | 2002-04-17 |
| K000378 | BACT/ALERT MB CULTURE BOTTLE | Organon Teknika Corp. | 2000-03-02 |
| K994343 | BACT/ALERT SV | Organon Teknika Corp. | 2000-02-10 |
| K993423 | BACT/ALERT SA | Organon Teknika Corp. | 1999-12-15 |
| K993576 | BACT/ALERT MP PROCESS BOTTLE | Organon Teknika Corp. | 1999-12-14 |
| K993421 | BACT/ALERT SN | Organon Teknika Corp. | 1999-12-14 |
| K992432 | BACT/ALERT FN | Organon Teknika Corp. | 1999-09-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00848838091841 | VersaTREK™ | REMEL, INC. | 2025-01-16 |
| 00382904454753 | BD BACTEC™ 9240 | BECTON, DICKINSON AND COMPANY | 2024-11-04 |
| 00382904455705 | BD BACTEC™ 9120 | BECTON, DICKINSON AND COMPANY | 2024-11-04 |
| 00848838091827 | NA | REMEL, INC. | 2022-04-21 |
| 00848838091711 | NA | REMEL, INC. | 2021-12-27 |
| 00848838091704 | NA | REMEL, INC. | 2021-12-27 |
| 00848838091698 | NA | REMEL, INC. | 2021-12-27 |
| 00848838091452 | NA | REMEL, INC. | 2021-12-27 |
| 00848838091445 | NA | REMEL, INC. | 2021-12-27 |
| 00848838091438 | NA | REMEL, INC. | 2021-12-27 |
| 00848838091124 | NA | REMEL, INC. | 2021-12-27 |
| 00848838091070 | NA | REMEL, INC. | 2021-12-27 |
| 00848838091056 | NA | REMEL, INC. | 2021-12-27 |
| 00848838091063 | NA | REMEL, INC. | 2021-12-27 |
| 03573026595906 | BACT/ALERT® FA | BIOMERIEUX , INC. | 2020-04-23 |
| 03573026595739 | BACT/ALERT® SA | BIOMERIEUX , INC. | 2020-04-23 |
| 03573026595722 | BACT/ALERT® PF | BIOMERIEUX , INC. | 2020-04-22 |
| 03573026595746 | BACT/ALERT® SN | BIOMERIEUX , INC. | 2020-04-21 |
| 00382904428051 | BD BACTEC™ Blood Culture Procedural Tray | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904422653 | BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904422608 | BD BACTEC™ Standard/10 Aerobic/F Culture Vials | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904421946 | BD BACTEC™ Peds Plus™/ F Culture Vials | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904421939 | BD BACTEC™ Plus Anaerobic/F Culture Vials | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904421922 | BD BACTEC™ Plus Aerobic/F Culture Vials | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904421915 | BD BACTEC™ Standard Anaerobic/F Culture Vials | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904420239 | BD BACTEC™ Plus Aerobic/F Culture Vials | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904420215 | BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904420208 | BD BACTEC™ Peds Plus™/F Culture Vials | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904420017 | BD BACTEC™ Blood Culture Procedural Tray 2 | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904420000 | BD BACTEC™ Blood Culture Procedural Tray 1 | BECTON, DICKINSON AND COMPANY | 2018-05-25 |